Congratulations! BiOptic's Analysis Software has certified by IEC 62304!

BiOptic Inc., as a biotechnology company with R&D, manufacturing, and marketing momentum. To extend the product market to clinical related fields, we followed all software develop guidelines for BiOptic instrument products and has been certified by FDA 21 CFR Part 11. Recently, the operation and database control system: Q-Analyzer and Qamp Master Micro PCR program software are also certified by IEC 62304.

The current version of IEC 62304 is IEC 62304:2006/AMD 1:2015, which is used to ensure the safeness and maintenance of medical equipment software. In order to provide users fully functioned quality control system for the use of Qsep series instruments and Qamp mini software, the BiOptic Inc. R&D team continues to optimize the development process and formulate relevant specifications. With the certification of IEC 62304, we provide end-users a great and safe experience.